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我正在生产一种物质的非纳米形态和纳米形态。注册和危险数据的吨位范围由什么决定?
问题(中文)
我正在生产一种物质的非纳米形态和纳米形态。注册和危险数据的吨位范围由什么决定?
Question (EN)
I am manufacturing both non-nanoforms and nanoforms of a substance. What determines the tonnage band for registration and for the hazard data?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
REACH 法规规定,吨位范围是按每个注册人的每个物质(包括非纳米形态和纳米形态)计算的。因此,注册义务取决于您生产或进口的物质的年度总吨位,包括非纳米形态和纳米形态。如果物质的总量超过每年 1 吨,则总量中的纳米形态也需要注册,即使它们的量少于每年 1 吨。同样,物质的总量(非纳米形态和纳米形态数量的累计)决定了适用的信息要求。总体积的信息要求适用于物质的非纳米形态和每个纳米形态,即使它们各自的体积代表较低的吨位范围。有关更多信息,请参阅适用于注册和物质识别指南的纳米形态附录,第 2.1 节注册义务。
Answer (EN)
The REACH Regulation states that the tonnage band is calculated per registrant per substance, including non-nanoforms and nanoforms. Thus, the registration obligation depends on the total yearly tonnage of the substance that you manufacture or import, including both non-nanoforms and nanoforms. If the overall volume of the substance is above 1 tonne per year, nanoforms within that total volume also need to be registered, even if they represent a volume of less than 1 tonne per year.
Similarly, the overall quantity of the substance, cumulating the quantity of both non-nanoforms and nanoforms, determines the applicable information requirements. The information requirements of the total volume apply to the non-nanoform and each of the nanoforms of the substance, even if their individual volumes represent a lower tonnage band.
For more information see the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, section 2.1 Registration obligations.